CareDx, Inc.

Hello, everyone. Thank you for joining us and welcome to the CareDx Q3 2026 earnings call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. I will now hand the conference over to Nina Deka, CareDx Head of Investor Relations. Nina, please go ahead.

Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CharityX released financial results for the third quarter of 2026, ending September 30th, 2026. The results and our earnings presentation are available on the company's website at charityx.com. Joining me on today's call are John Hanna, President and Chief Executive Officer, and Keith Kennedy, Chief Operating Officer and Chief Financial Officer. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that can cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. Information concerning the risks, uncertainties, and other factors that could cause results to differ from these forward-looking statements is included in our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, October 29, 2026. We disclaim any intention or obligation, except as required by law, to update or revise any information Financial Projections, or other forward-looking statements, whether because of new information, future events, or otherwise. This call will also include a discussion of certain non-GAAP financial measures. These non-GAAP financial measures should be considered in addition to, not as a substitute or in isolation from, GAAP measures. Reconciliations of our non-GAAP financial measures to the most directly comparable GAAP financial measures may be found in today's earnings release or investor presentation, which are posted on our website. With that, I will now turn the call over to John.

Thank you, Nina. Good afternoon, everyone, and thank you all for joining us today. We had another strong quarter of solid execution extending our leadership in transplantation, expanding into specialty oncology, and preparing for our entrance into cell therapy. As a reminder, Our strategy is to focus on markets where we believe our core competencies give us the right to win. Markets where patients face a high burden of disease and are managed by a concentrated group of subspecialty providers, where the high cost of treatment and disease management warrants repeat molecular testing, and where our solution selling approach, including integrated testing, digital solutions, and pharmacy, can create a competitive advantage. In my conversations with clinicians across transplantation, oncology, and cell therapy over the past quarter, the feedback is consistent. Clinicians want actionable precision molecular information about their patient's disease status and how it is changing over time to inform treatment decisions. Across these markets, our approach to driving growth is consistent generate the evidence that builds clinical belief and make testing easier to integrate into practice workflows. Today, I'll cover our progress across the growth drivers we use to execute this strategy, our pipeline, the evidence we're generating, and how we're executing in the market, including specialty oncology. I'm also excited to share later in my prepared remarks a new facet to our strategy and how we build meaningful connections with patients throughout their care journey. But first, let's talk about our pipeline. Innovation remains central to maintaining our leadership position, applying CareDx strengths in new markets and expanding our addressable market. Both of our organic pipeline programs are on track. For each pipeline program, we begin by generating evidence well before launch, so clinicians have the data they need to evaluate the test and understand how it can inform patient care. Let me start with Alloheme. We continue to advance Alloheme, our recurrence monitoring test for patients undergoing cell therapy to treat AML and MDS hematologic malignancies. Designed as a universal assay for cell therapy patients, Without reliance on a specific disease mutation, Alekheme represents an organic expansion of our capabilities into a market where we believe we have the potential to establish a differentiated leadership position. The Acrobat Clinical Validation Steering Committee has submitted the initial trial manuscript for peer review. Recall, at tandem earlier this year, the authors demonstrated that Alekheme identified molecular relapse A median of 41 days before clinical diagnosis. We remain on track to complete clear readiness activities before year-end, supporting a planned commercial launch in the first quarter of 2027. Histomath kidney, which adds a layer of molecular insights to tissue biopsy assessment, complementing alisher kidney blood-based monitoring, is also on track. This quarter, a second independent validation study performed in conjunction with investigators at the University of Wisconsin was published in the peer-reviewed journal Transplantation. Histomap's molecular classification exhibited robust concordance across established rejection categories. Importantly, the authors evaluated a subgroup of patients diagnosed with microvascular inflammation, or MVI. Previously, this pathology was often interpreted as no rejection. The clinical significance of this phenotype was elevated by a recent study published in the New England Journal of Medicine, which found that these patients had a significantly greater risk of graft loss than previously believed. In the transplantation article, HistoMath was able to identify two subgroups of patients with MVI that had meaningfully different long-term graft outcomes. Over follow-up of up to six years, 50% of patients molecularly classified by histamap as having a high risk of rejection experienced graft loss compared with 15% of those classified by histamap as having a low risk of rejection. This more than three-fold difference demonstrates Histomap's potential to identify clinically meaningful risk in the setting of MVI beyond conventional pathology. We remain focused on completing Histomap CLIA readiness activities before year end in support of a broader commercial availability in 2027. And as a reminder, in liver transplantation, we continue to collect and analyze follow-up data from patients enrolled in Maple, our multicenter prospective clinical validation study. Evidence generation is central to how we advance our pipeline. We are building the evidence needed to demonstrate clinical value and support future adoption and coverage. Turning now to evidence generation for our on-market products, evidence is how we build belief in molecular testing as standard of care. Our medical affairs team continues to strengthen the foundation for long-term growth by advancing clinical confidence in our testing portfolio and supporting the translation of evidence into clinical practice. I'll start with specialty oncology and then turn to transplant. In specialty oncology, NavDx is used for molecular residual disease, or MRD, testing in HPV-driven cancers. with surveillance as its first established context of use. Investigators are now exploring additional contexts of use, including radiation de-escalation in HPV-driven head and neck cancer. This is an important clinical question because the burden of radiation for head and neck cancer can be profound. Treatment typically lasts for six to seven weeks and the cumulative effects can make it difficult for patients to swallow, maintain nutrition, and manage everyday life, with some effects persisting long after treatment ends. If clinicians could safely reduce that burden for selected patients while maintaining disease control, even a shorter course or lower dose, that de-escalation could be meaningful. At the American Society of Radiation Oncology Conference, or ASTRO, Two independent Phase II studies utilizing NavDx in distinct radiation de-escalation settings were presented. The first evaluated radiation after surgery. In an independent prospective multicenter study, investigators at Emory and Vanderbilt used postoperative NavDx results to guide the subsequent radiation dose and treatment area. Among 35 patients, the study reported 97% control of the cancer in the treated region at 12 and 24 months, along with favorable patient-reported swallowing function at one year. These findings are early, but they illustrate one potential context of use for precision molecular information following surgery. The second study from Ohio State evaluated patients receiving radiation as their primary treatment. Investigators measured NavDx kinetics during treatment to determine which patients would receive a reduced radiation dose. In the first 15 patients, 12 had a greater than 95% decline in their NavDx score by week four and received a lower radiation dose than the current standard. All 12 achieved a complete response at three months with no cancer returning in the treated region at the interim analysis. Longer follow-up will be important, but the study demonstrates how NAVDx is being evaluated to tailor radiation based on an individual patient's response. Together, these two phase two trials evaluated two distinct contexts of use, guiding radiation after surgery and adapting definitive radiation during treatment to safely reduce the burden of radiation for selected patients while maintaining disease control. At ASTRO, more than 20 trials were highlighted exploring radiation de-escalation in this setting, underscoring the level of clinical interest in determining which patients may safely receive a lower dosage. A new study is also evaluating NavDx during the initial period after definitive radiation treatment and before the standard of care imaging assessment at month three. A newly published eight-center study in clinical cancer research led by investigators at Mount Sinai and Dana-Farber Cancer Institute evaluated 332 patients during this early post-treatment period. Patients whose results remained positive faced a much greater risk of recurrence, while no recurrences were observed among those whose results later became negative. The findings highlight the potential prognostic value of molecular results before the standard three-month imaging assessment. This illustrates how the evidence could expand NavDx beyond established surveillance and into additional treatment decisions across the patient journey. Turning to solid organ transplant, this fall, both at the Banff Meeting on Transplant Pathology and the American Society of Nephrology Kidney Week, or ASN, we presented new evidence that further demonstrates how molecular testing can help clinicians assess rejection risk, inform monitoring, and navigate some of the most difficult decisions in kidney transplant care. One of the key analyses comes from our CAOR Registry, and looks at a particularly challenging clinical scenario, patients with borderline changes or T-cell mediated rejection seen on biopsy where histology alone does not always predict who is at risk. In 131 patients, an Allishore kidney result of 1% or higher around the time of biopsy was independently associated with a nearly threefold higher risk of graft loss or a decline in kidney function of 30% or more. This could help clinicians identify higher risk patients who may benefit from closer monitoring, reinforcing Alloshore's role in informing care beyond a signal diagnostic decision. At ASN, investigators from the Paris Transplant Group presented results from a multinational randomized trial of 332 kidney transplant recipients. Patients monitored using an AlloSure-based monitoring strategy underwent 49% fewer biopsies between months three and 12 with similar rates of death, graft loss, and acute rejection, and no statistically significant difference in kidney function at 12 months. This is important prospective evidence Deporting the potential for molecular monitoring to reduce invasive procedures while maintaining comparable outcomes. Demonstrating that Allisher-based monitoring strategy can reduce invasive biopsies while maintaining similar clinical outcomes strengthens the clinical and health economic rationale for broader protocol adoption and payer coverage. Together, these findings demonstrate the growing breadth of the Allisher Kidney Evidence Base, helping clinicians assess risk when biopsy findings are ambiguous and informing monitoring strategies designed to reduce unnecessary procedures. Across the solid organ transplant and specialty oncology portfolios, we are focused not only on demonstrating test performance, but also on showing how our solutions can inform more clinical decisions and create value for patients, providers, and payers. That evidence is central to expanding use across our established portfolio and advancing our pipeline toward launch, reimbursement, and future coverage. Turning now to go to market, since we closed the acquisition of NavDx on July 1st, We've been executing against the three specialty oncology integration priorities I outlined last quarter, and I want to update you on each. First, we are leveraging our commercial capabilities to expand adoption of NavDx. We've started the expansion of our field team to build belief in NavDx testing as a standard of care for HPV-driven cancers. That added commercial and medical presence is intended to drive deeper adoption of protocols for MRD surveillance. In addition, our customer service team is making it easier for patients to access NABDx testing through blood draw scheduling and our national mobile phlebotomy network. Second, we are applying our clinical workflow optimization expertise to simplify the customer experience and support longitudinal testing. We have enabled electronic ordering through our Care Portal and see growing use of standard orders for surveillance testing and are integrating NavDx ordering into Epic Aura. We currently expect Epic-based ordering to begin by January 1st, 2027. Third, we are strengthening revenue cycle management execution. On October 1st, we move NavDx onto our CareDx billing platform. and brought in-house 100% of our RCM workflows, creating a more scalable operational foundation. As Keith will review, we are already seeing RCM collections momentum with NavDx. We believe these go-to-market workflow optimization and operational scale efforts position us to sustain NavDx growth through 2027, consistent with the guidance we shared when we announced the transaction. These are the same core capabilities that have made us the leader in solid organ transplant that we are now applying across specialty oncology. We have a repeatable model for translating differentiated science into clinically valuable solutions and bringing them to clinicians and patients at scale. Turning now to solid organ transplant go-to-market execution. I want to say that we are encouraged to see kidney disease elevated on the national agenda with the release of the new Health and Human Services Kidney Care National Plan. The scale of the need is profound. An estimated 36 million American adults are living with chronic kidney disease and most do not even know that they have it. More than 800,000 Americans are living with kidney failure including approximately half a million receiving dialysis and the hope of a transplant. More than 90,000 people remain on the kidney transplant wait list while only approximately 28,000 kidney transplants are performed each year. The asymmetry between the supply of transplantable organs and the demand is dramatic. Behind those numbers are patients and families living with the physical burden of dialysis and uncertainty of waiting and the hope that a transplant can offer a longer and fuller life. The Kidney Care National Plan recognizes the importance of preventing kidney failure where possible while expanding access to transplantation and encouraging innovation. We strongly share that goal, helping more patients who need a transplant receive one and supporting them throughout the transplant journey. Against that backdrop, transplant testing grew 21% in the quarter. We believe that momentum reflects our differentiated clinical evidence and continued investments in field execution, protocol adoption, and workflow integration. We increased our engagement with transplant centers, supported broader implementation of testing protocols, particularly in kidney and lung, and continued to make our solutions easier to incorporate into clinical practice. We now have 21 centers live on Epic Aura, bringing ordering, results, and longitudinal testing history into existing clinical workflows. We anticipate that we will achieve our goal of half our transplant orders flowing through EMR integrations by year end. We are also building stronger connections with patients throughout their care journey with the goal of helping them remain informed, engaged, and connected to ongoing monitoring. In Q3, we launched our new patient website, www.caredx.com, forward slash patients, a home for kidney, heart and lung transplant patients and caregivers. We want patients to feel supported long after surgery and to understand why ongoing monitoring matters. We believe greater engagement can support adherence and help patients stay connected to their care journey. Our new patient portal builds on that experience by connecting patients more directly to their Allishore results. As of this week, more than 5,000 patients have already registered for the portal. It gives them a simple way to access their latest results, see how those results have changed over time, and find relevant information that can help them understand the results in context. This addresses an important need for transplant patients who want to remain informed and connected to their care between visits. It is another way that we are differentiating, not only through our tests, but through the experience and support that we build around them. Now, I'd like to turn it over to Keith to walk you through our financial results. Keith?